Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug

NCT06265389 | Completed Phase 4

• 1 other identifier: Pentoxifylline in pneumonia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pentoxifylline is a xanthine-derived, commercially produced drug approved for the management of intermittent claudication in patients suffering from a chronic occlusive arterial disease of the limbs. Pentoxifylline has been documented to display anti-inflammatory and immunomodulatory effects, as well as some antithrombotic and antiviral effects. This drug has also been shown to reduce lung fibrosis in patients with COVID-19, as well as to prevent thromboembolic events. This work aims to assess the benefit of oral Pentoxifyllin supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community-acquired pneumonia

Conditions

Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia

Outcome Measures

Primary Outcomes (7)

• Respiratory distress

  Duration of improvement of respiratory distress

  3 days

• Temperature

  Duration of defeverness

  3 days

• Oxygen saturation

  Duration of normalization of hypoxia

  3 days

• CRP

  Duration of normalization of CRP

  5 days

• LDH

  Duration of normalization of LDH

  5 days

• D-dimer

  Duration of normalization of D-dimer

  5 days

• Interleukin 6

  Duration of normalization of IL-6

  5 days

Secondary Outcomes (2)

• Hospital stays

  14 days

• Pneumonia complications

  14 days

Other Outcomes (1)

• Surgical intervention

  14 days

Study Arms (2)

50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form

EXPERIMENTAL

50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form at a dose of 20 mg/kg/day, as an adjunct therapy to the usual pneumonia treatment for 5 days

Drug: Pentoxifylline Oral Tablet

50 children with community-acquired pneumonia with the standard pneumonia treatment.

NO INTERVENTION

50 children with community-acquired pneumonia with the standard pneumonia treatment as a control group

Interventions

Pentoxifylline Oral Tablet DRUG

50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form as an adjunct therapy to the usual pneumonia treatment for 5 days and the control group includes 50 children with community-acquired pneumonia with the standard pneumonia treatment.

Also known as: TRENtal

50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All children aged 2 months -18 years with community-acquired pneumonia diagnosed by signs and symptoms of CAP including; chest pain, dyspnea, tachypnea, or abnormal auscultatory findings plus focal findings on chest x-ray indicating community-acquired pneumonia

You may not qualify if:

• Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorders impacting respiration i.e. genetic, metabolic, neuromuscular disorders, and children with CHD affecting the pulmonary blood flow.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 37515, Egypt

Location

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: June 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)